Traditional Chinese medicine composition for regulating metabolism-related fatty liver of perimenopausal women as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention provides a traditional Chinese medicine composition for regulating metabolism-related fatty liver of perimenopausal women as well as a preparation method and application of the traditional Chinese medicine composition, and belongs to the technical field of traditional Chinese medicines. The traditional Chinese medicine composition is prepared from the following traditional Chinese medicine raw materials in parts by mass: 28 to 32 parts of radix rehmanniae preparata, 8 to 10 parts of honey-fried cortex pseudolaricis, 8 to 10 parts of deer-horn glue, 5 to 7 parts of semen brassicae, 5 to 7 parts of baked ginger, 14 to 16 parts of wine-processed cistanche deserticola, 28 to 32 parts of poria cocos, 1 to 2 parts of herba asari, 14 to 16 parts of radix paeoniae rubra, 8 to 10 parts of fried peach kernel and 0.8 to 1.2 parts of borneol. The traditional Chinese medicine composition disclosed by the invention is obtained by adding and subtracting medicines on the basis of Yanghe decoction and cassia twig and poria cocos pills, the traditional Chinese medicine composition is prepared into an external application patch, the external application patch is pasted on a corresponding acupuncture point, early warning and early intervention are combined with the idea of'preventive treatment of diseases', so that the traditional Chinese medicine composition is stably transited to menopause, metabolic diseases and even cardiovascular and cerebrovascular and tumor diseases are reduced, and the curative effect of the traditional Chinese medicine composition is improved. Therefore, the effect of treating both liver and spleen is achieved, and guarantee is provided for female health.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicines, and in particular relates to a traditional Chinese medicine composition for regulating metabolic-related fatty liver in perimenopausal women, and a preparation method and application thereof. Background Art

[0002] Metabolic-associated fatty liver disease (MAFLD) was called non-alcoholic fatty liver disease before it was renamed in 2020. It refers to a clinical pathological syndrome characterized by excessive fat deposition in hepatocytes caused by other clear liver-damaging factors other than alcohol. It is a common chronic liver disease worldwide and can further develop into liver fibrosis, cirrhosis, and even hepatocellular carcinoma. Metabolic-associated fatty liver accounts for the majority of fatty livers, which include a series of changes such as simple fatty liver, non-alcoholic steatohepatitis, and cirrhosis. In recent years, due to various reasons such as improved living standards, changes in dietary structure, lack of exercise, and drugs, the incidence of MAFLD has been increasing year by year and the age of onset has been younger. As a metabolic stress liver injury, MAFLD is closely related to insulin resistance and genetic susceptibility. MAFLD is not sub-health, but a disease, and it has seriously threatened people's health.

[0003] At present, prevention is the main approach for metabolic-related fatty liver at home and abroad. By adjusting diet and exercising appropriately, weight loss can be achieved slowly, insulin resistance can be improved, liver function can be improved, and liver histological lesions can be alleviated. Therefore, it is considered the most effective basic treatment measure. There is no specific drug for metabolic-related fatty liver yet. Summary of the invention

[0004] In view of this, the object of the present invention is to provide a Chinese medicine composition for regulating metabolism-related fatty liver in perimenopausal women, as well as a preparation method and application thereof.

[0005] The invention provides a traditional Chinese medicine composition, comprising the following traditional Chinese medicine raw materials in parts by weight: 28-32 parts of cooked rehmannia, 8-10 parts of honey ephedra, 8-10 parts of antler glue, 5-7 parts of white mustard seeds, 5-7 parts of roasted ginger, 14-16 parts of wine cistanche, 28-32 parts of tuckahoe, 1-2 parts of asarum, 14-16 parts of red peony root, 8-10 parts of stir-fried peach kernels and 0.8-1.2 parts of borneol.

[0006] Preferably, the Chinese medicinal raw materials are included in the following parts by mass: 30 parts of cooked rehmannia, 9 parts of honey ephedra, 9 parts of antler glue, 6 parts of white mustard seeds, 6 parts of roasted ginger, 15 parts of wine cistanche, 30 parts of poria, 3 parts of asarum, 15 parts of red peony root, 9 parts of stir-fried peach kernels and 1 part of borneol.

[0007] The invention provides a medicine for preventing and treating metabolism-related fatty liver, comprising the traditional Chinese medicine composition and a thickener.

[0008] Preferably, the Chinese medicine composition comprises fine powder or superfine powder.

[0009] Preferably, the thickener comprises egg white.

[0010] Preferably, the dosage form of the drug includes an external ointment.

[0011] Preferably, the external ointment comprises a patch.

[0012] Preferably, the patch comprises a non-woven fabric or a Chinese medicine composition mixed with a thickener attached to the non-woven fabric.

[0013] The present invention provides application of the traditional Chinese medicine composition in preparing a medicine for preventing and / or treating metabolism-related fatty liver.

[0014] Preferably, the dosage form of the drug includes an external dosage form.

[0015] The present invention provides a Chinese medicine composition, comprising the following Chinese medicine raw materials by weight: 28-32 parts of cooked rehmannia, 8-10 parts of honey ephedra, 8-10 parts of antler glue, 5-7 parts of white mustard, 5-7 parts of roasted ginger, 14-16 parts of wine cistanche, 28-32 parts of tuckahoe, 1-2 parts of asarum, 14-16 parts of red peony root, 8-10 parts of stir-fried peach kernel and 0.8-1.2 parts of borneol. The Chinese medicine composition of the present invention is obtained by adding and subtracting the medicinal flavors on the basis of Yanghe Decoction and Guizhi Fuling Pills. The Chinese medicine composition of the present invention can effectively treat metabolic-related fatty liver, and has the advantages of small side effects and rapid onset in terms of therapeutic effect.

[0016] The present invention provides a medicine for preventing and treating metabolic-related fatty liver, further limiting the Chinese medicine composition to carry out external treatment by acupoint application, having the advantages of convenient administration, wide adaptability, etc., adopting acupoint application Chinese medicine characteristic external treatment technology that is easy for patients to accept, the medicine has a good intervention effect on clinical metabolic indicators and endocrine rapid indicators, etc., greatly reducing the incidence of metabolic-related fatty liver and other diseases induced by it, and at the same time, the present invention takes perimenopausal women as research objects, combines the early warning and early intervention of the "preventive treatment" idea, so that it can smoothly transition to menopause and reduce the occurrence of metabolic diseases and even cardiovascular and cerebrovascular diseases, tumor diseases. It can be seen that the medicine provided by the present invention is externally used, combined with the early warning and early intervention of the "preventive treatment" idea, so that it can smoothly transition to menopause and reduce the occurrence of metabolic diseases and even cardiovascular and cerebrovascular diseases, tumor diseases, thereby achieving the effect of liver and spleen co-treatment, providing protection for women's health. DETAILED DESCRIPTION

[0017] The present invention provides a traditional Chinese medicine composition, comprising the following traditional Chinese medicine raw materials in parts by mass: 28-32 parts of prepared rehmannia root, 8-10 parts of honey-fried ephedra, 8-10 parts of deer horn glue, 5-7 parts of white mustard seed, 5-7 parts of prepared ginger, 14-16 parts of wine-processed cistanche, 28-32 parts of poria cocos, 1-2 parts of asarum, 14-16 parts of red peony root, 8-10 parts of stir-fried peach kernel, and 0.8-1.2 parts of borneol.

[0018] In the present invention, the traditional Chinese medicine composition preferably comprises the following traditional Chinese medicine raw materials in parts by mass: 30 parts of prepared rehmannia root, 9 parts of honey-fried ephedra, 9 parts of deer horn glue, 6 parts of white mustard seed, 6 parts of prepared ginger, 15 parts of wine-processed cistanche, 30 parts of poria cocos, 3 parts of asarum, 15 parts of red peony root, 9 parts of stir-fried peach kernel, and 1 part of borneol.

[0019] In the present invention, the traditional Chinese medicine composition is obtained by adding and subtracting the medicinal flavors based on the basic formula of Yanghe Decoction and Guizhi Fuling Pills. The Yanghe Decoction is mainly composed of traditional Chinese medicine materials such as prepared rehmannia root, cinnamon, ephedra, deer horn glue, white mustard seed, prepared ginger charcoal, and raw licorice root. The Yanghe Decoction has the effects of warming yang and nourishing blood, dispelling cold and dredging stasis. It is mainly used for treating diseases caused by yang deficiency and internal exuberance of yin cold, such as bone carbuncle, ischemic necrosis of toes (such as diabetic foot), deep-rooted abscess, phlegm node, and genu varum with flaccidity of the knee joint, etc., which belong to the syndrome of yin cold. Its characteristic is that it can both warm and tonify yang qi and promote blood circulation to remove blood stasis, and has a good effect on improving blood circulation and promoting the recovery of the diseased part. The Guizhi Fuling Pills are mainly composed of traditional Chinese medicine materials such as cinnamon twig, poria cocos, moutan bark, peach kernel, and white peony root. The Guizhi Fuling Pills have the effects of promoting blood circulation to remove blood stasis and slowly dissipating mass. It is applicable to symptoms such as women with a mass in the lower abdomen due to blood stasis, pain on pressing, abdominal pain during menstruation, and irregular menstruation. Modern research has found that it also has a certain role in regulating female endocrine and improving uterine blood circulation. The traditional Chinese medicine composition has a good therapeutic effect on the problems of yang deficiency and cold coagulation, and blood stasis blocking collaterals. Since patients with metabolic-related fatty liver show both obvious symptoms of yang qi deficiency and blood stasis manifestations, the traditional Chinese medicine composition can effectively reduce the triglyceride (TG) and total cholesterol (TC) in the serum, and at the same time reduce the activities of liver enzymes (alanine aminotransferase (ALT) and aspartate aminotransferase (AST)), reduce blood glucose concentration, improve insulin resistance problems. In addition, especially for perimenopausal women, it can improve endocrine indicators, smoothly transition to menopause, and reduce the occurrence of metabolic diseases, even cardiovascular and cerebrovascular diseases and tumors.

[0020] The present invention provides a drug for preventing and treating metabolic-related fatty liver, comprising the above-mentioned traditional Chinese medicine composition and a thickening agent.

[0021] In the present invention, the Chinese medicine composition preferably includes fine powder or ultrafine powder. The fine powder refers to a powder with a particle size distribution between about 40 μm and 75 μm. The fine powder is a powder material that can pass through a 200-mesh sieve. The ultrafine powder refers to a powder with an average particle size of less than 10 μm. The present invention has no special restrictions on the preparation method of the fine powder or ultrafine powder, and the conventional fine crushing method known in the art can be used.

[0022] In the present invention, the thickener preferably includes egg white. The egg white is taken before use to prevent the prepared medicine from being contaminated. The amount of egg white added is preferably such that the Chinese medicine composition is adjusted into a thick paste.

[0023] In the present invention, the dosage form of the drug preferably includes an external ointment. The external ointment preferably includes a patch. The patch preferably includes a non-woven fabric or a Chinese medicine composition mixed with a thickener attached to the non-woven fabric. The specification of the non-woven fabric in the patch is preferably 3cm×3cm. The amount of the Chinese medicine composition mixed with a thickener attached to each piece of non-woven fabric is 0.5 to 5g.

[0024] In the present invention, the drug is used for external application. The prepared drug patch is applied to the Shenque point, Mingmen point, and Qimen point once a day, with a break of one day every six days, and each time for 8 hours. Before external application, clean the Shenque point to keep it clean and dry, and observe whether there is skin allergy.

[0025] The present invention provides application of the traditional Chinese medicine composition in preparing a medicine for preventing and / or treating metabolism-related fatty liver.

[0026] In the present invention, the dosage form of the drug preferably includes an external dosage form.

[0027] The following is a detailed description of a Chinese medicine composition for regulating metabolic-related fatty liver in perimenopausal women provided by the present invention, as well as its preparation method and application, in conjunction with the embodiments. However, they should not be construed as limiting the scope of protection of the present invention.

[0028] Example 1

[0029] A method for preparing a drug for preventing and treating metabolic-related fatty liver

[0030] 1. Accurately weigh the following Chinese medicinal materials: 30g of cooked rehmannia, 9g of honey ephedra, 9g of antler glue, 6g of white mustard, 6g of roasted ginger, 15g of wine cistanche, 30g of poria, 3g of asarum, 15g of red peony root, 9g of stir-fried peach kernel and 1g of borneol.

[0031] 2. Preparation method: Grind the above drugs into fine powder (40μm~75μm), mix with egg white to make a thick paste, and add the prepared thick paste to about 3×3cm.

[0032] Example 2

[0033] A method for preparing a drug for preventing and treating metabolic-related fatty liver

[0034] 1. Accurately weigh the following Chinese medicinal materials: 32g of cooked rehmannia, 8g of honey ephedra, 10g of antler glue, 7g of white mustard, 5g of roasted ginger, 16g of wine cistanche, 28g of poria, 4g of asarum, 14g of red peony root, 10g of stir-fried peach kernel, and 2g of borneol.

[0035] 2. Preparation method: Grind the above drugs into fine powder (40μm~75μm), mix with egg white to make a thick paste, and add the prepared thick paste to about 3×3cm.

[0036] Example 3

[0037] A method for preparing a drug for preventing and treating metabolic-related fatty liver

[0038] 1. Accurately weigh the following Chinese medicinal materials: 28g of cooked rehmannia, 10g of honey ephedra, 8g of antler glue, 8g of white mustard, 7g of roasted ginger, 15g of wine cistanche, 32g of tuckahoe, 2g of asarum, 16g of red peony root, 11g of stir-fried peach kernel, and 3g of borneol.

[0039] 2. Preparation method: Grind the above drugs into fine powder (40μm~75μm), mix with egg white to make a thick paste, and add the prepared thick paste to about 3×3cm.

[0040] Example 4

[0041] Clinical efficacy verification of the drugs prepared in Examples 1 to 3

[0042] Female patients with clinically confirmed metabolic-related fatty liver disease were divided into two groups, with 21 people in each group:

[0043] Experimental group: The drugs prepared in Examples 1 to 3 were applied externally, specifically at the Shenque point, Mingmen point and Qimen point, once a day, with a break of one day every six days, each application for 8 hours, for a total of 4 weeks.

[0044] Control group: The patients' lifestyle was intervened for 4 weeks, and their daily routine was based on the ten health items, as follows:

[0045] 1. Go to bed between 21:00 and 22:00 at night and meditate for 10 to 30 minutes before going to bed;

[0046] 2. Get up between 5:00 and 6:00 in the morning;

[0047] 3. Drink hot water after waking up: you can add a little salt, ginger, jujube, or appropriate amount of honey;

[0048] 4. Morning exercise: For static exercise, you can choose Tai Chi, yoga, Yi Jin Jing, Ba Duan Jin, etc.; for dynamic exercise, you can choose running, cycling, etc. For the latter exercise, try to reach a heart rate of 170-age beats / minute;

[0049] 5. Breakfast: 7:00-9:00, try to eat rich and high-calorie breakfast;

[0050] 6. Lunch: Eat until you are full, and try to eat vegetarian;

[0051] 7. Lunch break: 11:00-13:00, no more than 30 minutes;

[0052] 8. Dinner: little or no. Cook fruits and vegetables when hungry and use the water to replace meals.

[0053] 9. Daily mobile phone holding time ≤ 1h / day;

[0054] 10.Great love, kindness, tolerance, and gratitude.

[0055] During the treatment period, no other drugs that protect liver and reduce enzymes or affect lipid metabolism were taken in both groups. The test time for both groups was 12 weeks.

[0056] The results showed that after treatment, the experimental group of patients detected triglycerides (TG) and total cholesterol (TC) in serum, reduced liver enzyme (alanine aminotransferase (ALT) and aspartate aminotransferase (AST)) activity, detected blood glucose concentration, and female endocrine indicators. The results showed that compared with before treatment, the drugs can reduce sugar and lipid metabolism indicators, endocrine hormone indicators, reduce triglyceride (TG) and total cholesterol (TC) content, and liver enzyme (alanine aminotransferase (ALT) and aspartate aminotransferase (AST)) activity, compared with the control group, there are significant differences. This shows that the drug provided by the present invention can effectively treat metabolic-related fatty liver.

[0057] The above is only a preferred embodiment of the present invention. It should be pointed out that for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principle of the present invention. These improvements and modifications should also be regarded as the scope of protection of the present invention.

Claims

1. A Chinese medicine composition, characterized in that: The invention comprises the following Chinese medicinal raw materials in parts by weight: 28-32 parts of cooked rehmannia, 8-10 parts of honey ephedra, 8-10 parts of antler glue, 5-7 parts of white mustard seeds, 5-7 parts of roasted ginger, 14-16 parts of wine cistanche, 28-32 parts of poria, 1-2 parts of asarum, 14-16 parts of red peony root, 8-10 parts of stir-fried peach kernels and 0.8-1.2 parts of borneol.

2. The Chinese medicine composition according to claim 1, characterized in that: The invention comprises the following Chinese medicinal raw materials in parts by weight: 30 parts of cooked rehmannia, 9 parts of honey ephedra, 9 parts of antler glue, 6 parts of white mustard seeds, 6 parts of roasted ginger, 15 parts of wine cistanche, 30 parts of tuckahoe, 3 parts of asarum, 15 parts of red peony root, 9 parts of stir-fried peach kernels and 1 part of borneol.

3. A drug for preventing and treating metabolic-related fatty liver, characterized in that: The invention comprises the Chinese medicine composition according to claim 1 or 2 and a thickener.

4. The drug according to claim 3, characterized in that The traditional Chinese medicine composition comprises fine powder or superfine powder.

5. The drug according to claim 3, characterized in that: The thickener includes egg white.

6. The drug according to claim 5, characterized in that: The dosage form of the drug includes an external ointment.

7. The drug according to claim 6, characterized in that: The external ointment includes a patch.

8. The drug according to claim 6, characterized in that: The patch comprises a non-woven fabric or a Chinese medicine composition mixed with a thickener and attached to the non-woven fabric.

9. Use of the Chinese medicine composition according to claim 1 or 2 in the preparation of a medicament for preventing and / or treating metabolism-related fatty liver.

10. The use according to claim 9, characterized in that: The dosage form of the drug includes an external dosage form.